Clinical Trials Coordinator

7 days ago

Toronto, Ontario, Canada Ozmosis Research Inc. Full time
About Ozmosis Research Inc.

Ozmosis Research Inc. is a leading independent clinical trials management company in Canada, operating as a social enterprise. We are a trusted partner for biotechnology and pharmaceutical companies, as well as academic institutions and investigators.

Job Summary

We are seeking a highly skilled Clinical Trials Specialist to join our team. The successful candidate will participate in project management of clinical trials from protocol development and review through to activation, follow-up, and trial closure.

Key Responsibilities
  • Project management of clinical trials, including protocol development, review, and approval
  • Coordinating local and international multicenter studies
  • Protocol development, writing, and amendments
  • Site activations, ongoing management, and close-outs
  • Communication with various stakeholders, including sites, staff, and sponsors
  • Vendor management
  • Utilize quality assurance procedures to ensure high-quality data
  • Ensure studies are conducted in accordance with ICH-GCP, Health Canada, FDA, and US Federal Code, as well as other regulatory agencies
Qualifications
  • Completion of a Bachelor's of Science degree or recognized equivalent required
  • Completion of a postgraduate certificate in Clinical Research or Project Management or recognized equivalent preferred
  • At least 3 years of experience in clinical trials required
  • Experience in critical care/ICU-based research, platform trials, international trial management, and device research preferred
  • SoCRA or ACRP designation, preferred
Skills and Competencies
  • Experience in project and clinical site management
  • Possess initiative and good judgment with the ability to multi-task
  • Strong critical thinking abilities
  • Ability to work under pressure and attention to detail
  • Demonstrated proficiency in English grammar, with excellent oral and written communication skills
  • Excellent organization and prioritization skills
  • Ability to learn quickly and work independently
  • Ability to perform duties in a professional and courteous manner and produce high-quality work while meeting deadlines
  • Ability to work well as part of a team
  • Knowledge of applicable legislation and regulations
  • Demonstrated proficiency in MS Office Suite (Word, Excel, and PowerPoint)
  • Experience in REDCap an asset

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